中美仿制药研发申报流程.ppt

文档介绍：中美仿制药研发和申报流程
涂家生,
中国药科大学药剂学教授
Te|:025-83271305
Email:******@

主要内容
图
中美关手原研药和仿制药的背景
2
美国仿制药:申报、基于问题的
审评利时发对第
3我国仿制药申报、审评和研发
4展望
药物经济学催生美国仿制药制度
美国社会安全制度导致政府赤字严重
SSA已经破产:如何破局?
降低医疗费用成为必然
Hatch- Waxman法案出台
美国FDA药品注册申请:新药(两类)、仿制药和
非处方药申请
1984年后
New Drug Applications
Abbreviated New Drug
(NDAS
Applications(ANDAS
“Fu∥ Reports" of safet
Duplicate of an already
and Efficacy Investigations
approved product
Applicant has right of
No safety/efficacy data
ce to essential
investigations?
bioequivalence)
505(b)(1)
505(b)(2)
505()
NDA的研发和申报
PRECLINICAL
R三 SEARCH
CLINICAL STUDIES
NDA REIEW
PHA SE1
八 ND PLI RIFICATION
PHASE
ACCELERATED DEVELOPMENT/REVIEW
ANIMAL
TESTINO
IREATMENT I
HORT-TERM
FARAL
LONG-TERM
TITUTIONAL
IEw BOARDS
INDUSTRY TIME
IND SUBMITTED
N DA SUBMITTED REVIEW气
SPONSORIFDA MEETINGS ENCOURA GEI
具匚cs
SPONSOR A
FROM REVIEw
505(6)(1)新药申报资料内
1. Index
2. Summary
3. Chemistry Manufacturing and Control
4. Samples, Methods Validation Package and
Labelin
5. Nonclinical Pharmacology and Toxicology
6. Human Pharmacokinetics and Bioavailability
7. Microbiology for anti-microbial drugs only)
8. Clinical data
9. Safety Update report typically submitted
120 days after the NDA's submission
10. Statistical
11. Case Report Tabulations
12. Case Report Forms
13. Patent information
14 Patent certification
505(b)(2):历史过程
Hatch Waxman法案:1984
. Parkman Letter
Phantom aNDa
FDA Draft Guidance for Industry
(1999)
FDA Response to citizen's Petition
(2003)
可以降低研发的费用和审评力量的浪费
505(b)(2)的关键:可靠性
s What is Reliance
By whom?
On What?
Reliance and Exclusivity
Market VS Data Exclusivity
Safety /Efficacy Data Vs CM&c data
FDA Process for Determining Reliance
Who when and how?